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SciSparc | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

SciSparc | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

SciSparc | 6-K:外國發行人報告
美股SEC公告 ·  09/23 21:13

牛牛AI助理已提取核心訊息

SciSparc Ltd., a clinical-stage pharmaceutical company, announced on September 23, 2024, that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application, allowing the company to proceed with Phase IIb clinical trials for its drug candidate SCI-110, aimed at treating Tourette Syndrome (TS) in adult patients. The trials will be conducted at three global leading centers, including the Yale Child Study Center in the U.S., Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. Institutional Review Board approvals have been secured for all sites. The trial will assess the efficacy, safety, and tolerability of SCI-110, with patients randomized to receive either the drug or a placebo. The primary efficacy...Show More
SciSparc Ltd., a clinical-stage pharmaceutical company, announced on September 23, 2024, that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application, allowing the company to proceed with Phase IIb clinical trials for its drug candidate SCI-110, aimed at treating Tourette Syndrome (TS) in adult patients. The trials will be conducted at three global leading centers, including the Yale Child Study Center in the U.S., Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. Institutional Review Board approvals have been secured for all sites. The trial will assess the efficacy, safety, and tolerability of SCI-110, with patients randomized to receive either the drug or a placebo. The primary efficacy measure will be the change in tic severity using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. SciSparc's CEO, Oz Adler, expressed confidence in the potential of SCI-110 to offer a novel treatment for TS, following swift FDA approval and positive results from the previous Phase IIa trial. SciSparc specializes in cannabinoid-based pharmaceuticals and is also engaged in drug development programs for Alzheimer's disease, agitation, Autism Spectrum Disorder (ASD), and status epilepticus.
SciSparc Ltd.,一家處於臨床階段的藥品公司,於2024年9月23日宣佈,美國食品藥品監督管理局(FDA)已批准其新藥申請(IND),允許該公司進行旨在治療成人特發性抽動症(TS)的候選藥SCI-110的IIb期臨床試驗。試驗將在三個全球領先中心進行,包括美國的耶魯兒童研究中心,德國的漢諾威醫學院以及以色列的特拉維夫索拉斯基醫療中心。所有研究機構審查委員會都已批准了這些試驗點。試驗將評估SCI-110的療效、安全性和耐受性,患者將被隨機分配接受藥物或安慰劑。主要療效測量將是使用耶魯全球抽動症嚴重程度評分表,在第12周和第26周與基線相比變化。SciSparc的首席執行官奧茲•阿德勒對SCI-110有望提供新穎的TS治療方法表示信心,這得益於FDA的快速批准和上一個IIa期試驗的積極結果。SciSparc專注於以大麻爲基礎的藥品,並且還在進行治療阿爾茨海默氏病、焦慮、自閉症譜系障礙(ASD)以及癲癇持續狀態的藥物開發項目。
SciSparc Ltd.,一家處於臨床階段的藥品公司,於2024年9月23日宣佈,美國食品藥品監督管理局(FDA)已批准其新藥申請(IND),允許該公司進行旨在治療成人特發性抽動症(TS)的候選藥SCI-110的IIb期臨床試驗。試驗將在三個全球領先中心進行,包括美國的耶魯兒童研究中心,德國的漢諾威醫學院以及以色列的特拉維夫索拉斯基醫療中心。所有研究機構審查委員會都已批准了這些試驗點。試驗將評估SCI-110的療效、安全性和耐受性,患者將被隨機分配接受藥物或安慰劑。主要療效測量將是使用耶魯全球抽動症嚴重程度評分表,在第12周和第26周與基線相比變化。SciSparc的首席執行官奧茲•阿德勒對SCI-110有望提供新穎的TS治療方法表示信心,這得益於FDA的快速批准和上一個IIa期試驗的積極結果。SciSparc專注於以大麻爲基礎的藥品,並且還在進行治療阿爾茨海默氏病、焦慮、自閉症譜系障礙(ASD)以及癲癇持續狀態的藥物開發項目。

譯文內容由第三人軟體翻譯。


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